Effect of Extracorporeal Shock Wave Therapy on Spasticity and Mobility in Stroke Patients

NCT07523243 | Not Yet Recruiting

• 2 other identifiers: IMU-2026IMU-2026 -STROKE
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) in individuals with lower limb spasticity following stroke. Spasticity is a common complication after stroke and can negatively affect walking ability, mobility, and quality of life. Participants will be randomly assigned to one of two groups. Both groups will receive a standard physiotherapy and rehabilitation program. In addition, the intervention group will receive ESWT applied to the lower limb muscles, while the control group will receive a sham (placebo) ESWT application. The treatment program will be conducted three times per week for four weeks. Clinical assessments will be performed at baseline, after treatment, and during follow-up. The main outcomes of the study include muscle tone (spasticity), walking performance, motor function, and quality of life. The results of this study may help improve rehabilitation strategies and provide evidence for the use of ESWT in stroke patients.

Conditions

Stroke; Post-Stroke Spasticity; Lower Limb Spasticity

Keywords

Extracorporeal Shock Wave; ESWT Stroke Rehabilitation; Mobility Fugl-Meyer; Quality of Life; Spasticity

Outcome Measures

Primary Outcomes (1)

• Change in Spasticity Assessed by Modified Ashworth Scale (MAS)

  Spasticity will be assessed using the Modified Ashworth Scale (MAS), a 6-point ordinal scale ranging from 0 (no increase in muscle tone) to 4 (rigidity). The assessment will be performed on the ankle plantar flexor muscles. A decrease in MAS score indicates improvement in spasticity. Spasticity will be assessed using the Modified Ashworth Scale (MAS), a 6-point ordinal scale ranging from 0 to 4, where: 0 = No increase in muscle tone 1 = Slight increase in muscle tone 1+ = Minimal resistance through less than half of the range 2 = More marked increase in tone 3 = Considerable increase in tone 4 = Rigid in flexion or extension The assessment will be performed on the ankle plantar flexor muscles. Higher scores indicate greater spasticity (worse outcome), while lower scores indicate improvement.

  Baseline, 4 weeks (post-treatment), and 8 weeks (follow-up)

Secondary Outcomes (5)

• Change in Walking Speed Assessed by 10-Meter Walk Test (10MWT)

  Baseline, 4 weeks, 8 weeks

• Change in Functional Mobility Assessed by Timed Up and Go Test (TUG)

  Baseline, 4 weeks, 8 weeks

• Change in Motor Function Assessed by Fugl-Meyer Assessment - Lower Extremity (FMA-LE)

  Baseline, 4 weeks, 8 weeks

• Change in Functional Exercise Capacity Assessed by 6-Minute Walk Test (6MWT)

  Baseline, 4 weeks, 8 weeks

• Change in Health-Related Quality of Life Assessed by Stroke-Specific Quality of Life Scale (SS-QOL)

  Baseline, 4 weeks, 8 weeks

Study Arms (2)

ESWT Group

EXPERIMENTAL

Participants in this group will receive extracorporeal shock wave therapy (ESWT) applied to the gastrocnemius and soleus muscles in addition to a standard physiotherapy program including stretching, strengthening, balance, and gait training.

Device: Extracorporeal Shock Wave Therapy (ESWT)

Control Group (Sham ESWT)

SHAM COMPARATOR

Participants in this group will receive sham ESWT with no therapeutic energy delivery in addition to the same standard physiotherapy program.

Device: Sham Extracorporeal Shock Wave Therapy

Interventions

Extracorporeal Shock Wave Therapy (ESWT) DEVICE

Radial extracorporeal shock wave therapy will be applied with an energy flux density of 0.10-0.20 mJ/mm², frequency of 5-8 Hz, and 2000-3000 pulses per muscle. Treatment will be administered three times per week for four weeks.

ESWT Group

Sham Extracorporeal Shock Wave Therapy DEVICE

A sham ESWT procedure will be performed using the same device without energy transmission, mimicking the sound and sensation of treatment.

Control Group (Sham ESWT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years
• Diagnosed with ischemic or hemorrhagic stroke at least 3 months prior to enrollment Presence of lower extremity spasticity with a Modified Ashworth Scale (MAS) score ≥1+
• Ability to walk independently with or without assistive devices
• Ability to understand and follow instructions for exercise interventions and assessments
• Provided written informed consent

You may not qualify if:

• Receipt of botulinum toxin injection in the affected lower limb within the last 3 months
• Severe cognitive impairment preventing participation in assessments
• Presence of fixed joint contractures limiting range of motion
• Orthopedic or musculoskeletal disorders affecting lower limb function (e.g., fracture, severe osteoarthritis)
• Uncontrolled cardiovascular, respiratory, or systemic disease contraindicating exercise
• Participation in another interventional clinical trial
• Any condition judged by the investigator to interfere with participation or safety

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Mehmet Salih SALİH TAN, Doctoral

CONTACT

Türkiye; mstan@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study is designed as a single-blind trial. Participants will be blinded to group allocation through the use of sham ESWT in the control group. Outcome assessors will also be blinded to the intervention groups. The therapist delivering the treatment will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned to one of two parallel groups: an intervention group receiving extracorporeal shock wave therapy (ESWT) in addition to standard physiotherapy, and a control group receiving sham ESWT along with the same physiotherapy program. Outcomes will be compared between groups over time.

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available starting 3 months after publication of the primary study results and will remain accessible for 5 years.
• Access Criteria: Qualified researchers affiliated with recognized academic or clinical institutions may request access to de-identified participant data and supporting documents. Requests must include a research proposal and signed Data Use Agreement to ensure confidentiality and adherence to ethical standards. Access will be provided via secure data transfer or a controlled-access repository managed by the study coordinating center.